The main market opportunities lie in adapting FDA-regulated computer system validation methods to align with GAMP®5 Second Edition and CSA, embracing innovative technologies like AI, ML, and ...
The market opportunities lie in providing comprehensive training for computer system validation aligning with FDA regulations, offering hands-on practice, agile and waterfall methodologies comparison, ...
On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic ...
Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation is ...
DUBLIN--(BUSINESS WIRE)--The "Digital Validation Demystified - GAMP® 5 2.0 and CSA Integration" training has been added to ResearchAndMarkets.com's offering. This course equips you with the tools, ...
DUBLIN--(BUSINESS WIRE)--The "Computer System Validation for Cloud and COTS Applications-Live Online Training" training has been added to ResearchAndMarkets.com's offering. Advancements in technology ...
A straightforward path toward regulatory compliance, data integrity, and computer systems validation
Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...
Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from ...
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